Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

https://www.tinnitustalk.com/threads/neramexane-for-tinnitus.1334/#post-10926

Neramexane failed at phase 3?

 

The first company to create relief or cure gets the billion dollar prize. Its that simple.

 

And that will be Autifony. I do hope they fast-track within the UK, if the results are promising.

 

how fast do they go from phase 3 to market in England danny?? Is their another example of a drug that went trough fast track??

 

http://www.bbc.co.uk/news/health-22556736

Wonder if the below link helps to answer your question

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4207.htm

and this is what happens when things go wrong
http://www.bbc.co.uk/news/health-22556736

 

Hi all,

I bring very bad news unfortunately. I got a call on Friday from the hospital where I was scheduled for the eligibility test in early November, saying that the QUIET-1 trial is stopping. I was told the researchers started analyzing the results and found no evidence the drug is working.
I'm sorry I don't have more information but I was in between flights and the call left me completely stunned. I'll try to gather more info on Monday.
Like everyone, I somehow hope this is just a bad dream or Autifony has something else up their sleeve, but I can assure you the call was very real.

@Markku

 

Cambridge

 

And this was my only hope. Devestating news, just devestating!

 

@David Ho ask the hospital for the official written statement and see what they send out. I'm not questioning the phone call, it's just that until there is something in writing I don't believe it can be properly reported. For all we know it could have been a clerical error in the communications.

 

Yes I'll e-mail them tomorrow to ask if/when official information is to be released.

 

What about the US trial for hearing loss?

https://www.clinicaltrials.gov/ct2/show/NCT02345031?term=autifony&rank=2

It looks like they're recruiting in some locations. The drug might still hit the market and be used for T "off label". And, whatever happens, they have to release a Phase II trial statement at the end of the trial, interrupted or not.

 

depressed by this news if its true..................

 

The hospital I spoke to about the trial said when I asked " with what you know so far will there be a Phase 3 " the reply was yes

 

Is it standard practice for a Phase 2 clinical trial to be abandoned mid-way through due to initial findings showing no indication of success? I don't know the answer to this question, maybe someone else will know.

I would have thought that once a clinical trial has started, it will normally proceed through to completion and publication of results. Unless there were problems with the testing methodology, inability to recruit sufficient numbers of eligible participants or concerns about the integrity of the test data, I'd be surprised if they decided to abandon the Phase 2 trial at this stage.

Is there a possibility that the people at Cambridge who contacted @David Ho were merely saying that the Cambridge site is no longer involved in the trial, rather than saying that the whole trial is being abandoned?

 

any one speak english very well can contact them to this numbre

 

They said the study was being stopped because researchers found the drug wasn't working when analyzing the available data.
Nothing in the conversation indicated this was a site-specific decision but I could (and indeed hope) be wrong.

 

The clinical trials record was last updated on September 28 and does not indicate that the trial is over. I've looked at the clinicaltrials.gov page a number of times, and I seem to recall some or all of those three sites always saying "Active, not recruiting". I don't know if that means that they achieved their quota of participants (if there is such a thing) early and do not need any more participants or if they are behind and just not recruiting. Does anyone know of anyone who participated at one of those locations?

As I understand it, trials are stopped early for 2 reasons: 1) adverse events due to the trial drug, or 2) large positive benefits such that it is unethical to continue to give some patients the placebo. It would seem out of the ordinary to stop data collection based on preliminary data analysis.

 

I became aware of the development yesterday evening via another source. I have sent a mail to the CEO, Mr. Charles Large, today asking if he would be kind to comment on the information.

attheedgeofscience
11/OCT/2015.

 

Ateos,

Agreed, let's hear it from the horses mouth, before pushing the panic button.

 

Agree, I can't see how it would have stopped early so I imagine there is a different explanation here. But until we hear it from Autifony its all speculation, very easy indeed for things to be communicated wrongly and rumours to spiral out of control.

 

Yes agreed but I just read online that trials can be stopped early due to ''futility'' reasons..but it does seem odd though yes....best lets not speculate but wait.....

 

So now people will say i told u so(if autifony fails),they can be happy?

so nothing, fake Am-101 it is. And now it autifony if it falls we are on the zero again

i am shocked no medicine for us, just may some help maybe maybe with am 101, and nothing for us who have tinnitus, and am 101 is very questionable, but we will see if they get to market at all... i hope they help at least something to SOMEONE if not me at least someone if it can.

A very gray day, a sad day, and blood moon is rising.

 

Remember: These pharma companies just began trying out new drugs in the past five years. IF we lose Aut, it will be a loss. But guess what? We're just in the beginning of a new age on T research. We finally know where to target (the brain, more specifically, quite possibly the potassium channels). Yeah, it will take time. But we're not alone. People are living with neurodegenerative disorders. People are living with chronic pain (100 million in America, to be exact... even more than T!). All we can do is do our best to enjoy the ride.

My favorite quote from Shawshank Redemption: "Remember Red, hope is a good thing, maybe the best of things, and no good thing ever dies."

Regardless of what happens with Aut. Never lose hope.

 

Why dont we wait till tomorrow and then we can find out exactly what is going on which is probably nothing and the trial continues......we cant find out anything on a sunday or weekend.....and I am shocked that a company would give out such highly confidential info to a person on the phone......not saying the phone call or content didnt happen but could just be nonsense from an un clued up hospital staff person....just wait till tomorrow to find out without all this useless speculation...............wonder what it was that markuu and ATEOS heard then? curious.....

 

This.
And if it doesnt work, its better to cancel it now, than lets say 2017. But we better wait till the company respond officially.

 

You cant just cancel a double blind trial before all the data has been collated unless they have screwed up their double blind trials OR someone had a very nasty side effect potentially dangerous to life and health from the drug.......they have not had the full quota of trial people yet which is why the trial time was extended to the end of this year......why would they extend and then give up nearly at the end.....does not make any sense at all........stop speculating and lets find out tomorrow Monday what is what

 

In UK fake calls are common! U all know for this one about Kate Middleton.
http://www.theguardian.com/world/20...call-duchess-cambridge-australian-djs-inquest

Lets hope AUT call, was something like this one...